Drug-Eluting Balloon in peripherAl inTErvention for Below the Knee Angioplasty Evaluation - DEBATE-BTK


The goal of the trial was to evaluate treatment with paclitaxel drug-eluting balloon angioplasty compared with conventional balloon angioplasty among diabetic patients with significant below-the-knee peripheral arterial disease.


Paclitaxel drug-eluting balloon angioplasty will reduce restenosis.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Diabetic patients with severe below-the-knee peripheral arterial disease defined as: 1) critical limb ischemia (Rutherford ≥4), or 2) stenosis or occlusion >40 mm of at least one below-the-knee vessel with distal run-off

    Number of screened applicants: 156
    Number of enrollees: 132
    Duration of follow-up: 12 months
    Mean patient age: 74 years
    Percentage female: 17%


  • Life expectancy <1 year
  • Allergy to paclitaxel
  • Contraindication to antiplatelet therapy
  • Planned major amputation

Primary Endpoints:

  • Binary in-segment restenosis, by angiogram or ultrasound, at 1 year

Secondary Endpoints:

  • Clinically driven TLR
  • Major amputation
  • Target vessel occlusion

Drug/Procedures Used:

Diabetic patients with significant below-the-knee peripheral arterial disease were randomized to paclitaxel drug-eluting balloon angioplasty (n = 65) versus conventional balloon angioplasty (n = 67).

Inflation time of the study balloon was at least 2 minutes. Drug-eluting coronary stents could be used as a bail-out.

Concomitant Medications:

During the procedure, all patients received aspirin and unfractionated heparin. Post-procedure, patients received life-long aspirin and clopidogrel for at least 4 weeks.

Principal Findings:

Overall, 132 patients were randomized. The mean age was 74 years, 17% were women, 20% were smokers, mean ankle brachial index was 0.31, mean Rutherford class was 5.2, 78% had complete vessel occlusion, mean lesion length was 129 mm, and procedural success was achieved in 100%.

Binary restenosis occurred in 27% of the drug-eluting balloon group versus 74% of the conventional balloon angioplasty group (p < 0.001).

- Target lesion revascularization (TLR): 18% vs. 43% (p = 0.002), respectively
- Major amputation: 0 vs. 1.5% (p = 0.9), respectively
- Complete ulcer healing: 86% vs. 67% (p = 0.01), respectively


Among diabetic patients with significant below-the-knee peripheral arterial disease, the use of the paclitaxel drug-eluting balloon significantly reduced restenosis and TLR compared with conventional balloon angioplasty. A drug-eluting balloon strategy may also improve the rate of ulcer healing. Further study of this technology is warranted.


Liistro F, Porto I, Angioli P, et al. Drug-Eluting Balloon in peripherAl inTErvention for Below the Knee Angioplasty Evaluation (DEBATE-BTK): A Randomized Trial in Diabetic Patients With Critical Limb Ischemia. Circulation 2013;Jun 24:[Epub ahead of print].

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and Vascular Medicine

Keywords: Paclitaxel, Follow-Up Studies, Ulcer, Ankle Brachial Index, Peripheral Arterial Disease, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents

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